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- Essai clinique NCT01230710
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
24 mars 2015 mis à jour par: Hoffmann-La Roche
A Multi-centre, Open-label, Phase IV, Interventional Study to Evaluate the Efficacy of Erlotinib (Tarceva®) Following 4 Cycles of Platinum-based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression.
Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
51
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Bangalore, Inde, 560027
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Chennai, Inde, 600035
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Delhi, Inde, 110085
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Hyderabad, Inde, 500 034
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Jaipur, Inde, 302 017
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Kolkata, Inde, 700026
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Nasik, Inde, 422005
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Adult patients ≥ 18 years of age.
- Histologically documented non-small cell lung cancer (NSCLC).
- Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
- Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients of reproductive potential must agree to use effective contraception.
Exclusion Criteria:
- Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
- Prior treatment with any monoclonal antibody therapy.
- Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
- Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
- Pre-existing interstitial lung disease.
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Pregnant or lactating women.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Erlotinib
Participants received erlotinib 150 mg orally once a day for 48 weeks.
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Erlotinib was supplied as tablets.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of Participants With Progression-free Survival at Week 52
Délai: From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
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A participant had progression-free survival if they did not have disease progression and were alive.
Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions.
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline.
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
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From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression-free Survival (PFS)
Délai: From the date of enrolment until the end of the study (up to 2 years, 6 months).
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PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first.
Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs.
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline.
TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Overall Survival
Délai: From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Overall survival was defined as the time from the date of enrolment to the date of death from any cause.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)
Délai: From the date of enrolment until the end of the study (up to 2 years, 6 months).
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A CR was defined as the disappearance of all target lesions.
A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter.
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline.
All other lesions (or sites of disease) should be identified as non-target lesions.
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Percentage of Participants With Disease Control
Délai: From the date of enrolment until the end of the study (up to 2 years, 6 months).
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A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1.
A CR was defined as the disappearance of all target lesions (TL).
A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD).
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started.
For non-TLs, SD was defined as the persistence of 1 or more lesions.
PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
A SLD for all TLs will be calculated and reported as the Baseline SLD.
Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2011
Achèvement primaire (Réel)
1 septembre 2013
Achèvement de l'étude (Réel)
1 septembre 2013
Dates d'inscription aux études
Première soumission
28 octobre 2010
Première soumission répondant aux critères de contrôle qualité
28 octobre 2010
Première publication (Estimation)
29 octobre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 mars 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 mars 2015
Dernière vérification
1 mars 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Attributs de la maladie
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Évolution de la maladie
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Inhibiteurs de protéine kinase
- Chlorhydrate d'erlotinib
Autres numéros d'identification d'étude
- ML25478
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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